01 1GE Healthcare Inc
02 1Jungbunzlauer International AG
01 1ANHYDROUS CITRIC ACID
02 1FASTLAB FDG CITRATE CASSETTE PACK
01 1Switzerland
02 1United Kingdom
01 2Active
01 1Complete
02 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 25371
Submission : 2011-10-07
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-10-07
Pay. Date : 2013-09-27
DMF Number : 23078
Submission : 2009-08-28
Status : Active
Type : II
A Citric Acid manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Citric Acid, including repackagers and relabelers. The FDA regulates Citric Acid manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Citric Acid API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
click here to find a list of Citric Acid manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Citric Acid supplier is an individual or a company that provides Citric Acid active pharmaceutical ingredient (API) or Citric Acid finished formulations upon request. The Citric Acid suppliers may include Citric Acid API manufacturers, exporters, distributors and traders.
click here to find a list of Citric Acid suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Citric Acid DMF (Drug Master File) is a document detailing the whole manufacturing process of Citric Acid active pharmaceutical ingredient (API) in detail. Different forms of Citric Acid DMFs exist exist since differing nations have different regulations, such as Citric Acid USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Citric Acid DMF submitted to regulatory agencies in the US is known as a USDMF. Citric Acid USDMF includes data on Citric Acid's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Citric Acid USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Citric Acid suppliers with USDMF on PharmaCompass.
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